Pyramid Consulting Inc.
Alpharetta, GA
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Job Description :
Immediate need for a talented Senior Project Manager. This is a 06+ Months contract opportunity with long-term potential and is located in Framingham, MA (Onsite). Please review the job description below and contact me ASAP if you are interested. 
 
Job ID:  23-32721  
 
Pay Range: $90 - $100/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
 
Key Responsibilities:
  • Problem Solving:-Provide technical solutions to a wide range of difficult problems through individual efforts as well as strategic leveraging of outsourced personnel.
  • Solutions are imaginative, thorough, practical, and consistent with organization objectives.
  • Production:-Responsible for ensuring MES and potentially other manufacturing related computerized systems are available to support Operations Schedule Adherence requirements.
  • Managing small to medium projects related to MES and ensuring that the appropriate controls, approvals, and validation requirements are implemented.
  • Training /Deviations /Compliance:-Complying with *** requirements for training, maintaining training at or above 95% on time.
  • Utilizing quality systems to measure, analyze, and improve team performance.
  • Participate in staff meetings, providing updates of department activities and project statuses.
  • Ensuring that Process, Equipment and MES documentation is compliant and inspection ready.
  • Participating in inspections conducted by external regulators.
  • Partnering with direct and indirect management chain to ensure the following:
  • Designing Department Training Plan and managing execution.
  • Ensuring Inspection Readiness of assigned areas.
  • Overseeing completion of investigations and deviations.
  • Safety-Complying with requirements from ***'s Safety Program including Health and Safety regulations and OSHA requirements.
  • Continuous Improvement:-Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner.
  • Identifying opportunities to improve manufacturing processes and practices.
  • Ensuring all manufacturing management tools/systems and documentation (SOPs, MBR's, OJTs) is accurate.
  • Partnering with Manufacturing to troubleshoot and drive resolution of process issues and proactively driving projects to improve manufacturing process.
  • Partnering with Operational Excellence to drive business process improvements through Kaizens, Kanban, 5S and VSM in their area of responsibility.
  • Ensuring that internal customers and suppliers are aligned with the solutions and services of the department.

Requirements and Technology Experience: 
  • Bachelor’s degree in Engineering, Science and 1 to 2 years relevant work experience or 5 years of relevant work experience.
  • 1 year of electronic batch record editing experience with one of these MES Systems Koerber/Werum PASX, Emerson Syncade, Siemens Op Center, or Rockwell- FactoryTalk Production Centre.
  • Direct experience with regulated environments (i.e. cGMP, OSHA, EPA).
  • Demonstrated knowledge of validation requirements for control systems in CGMP and/or ASTM environments.
  • Preferred Qualifications:-Master’s with 1+ years of relevant work experience.
  • MES Koerber/Werum Client-X batch record editing experience.
  • Experience in OSI PI system maintenance and configuration activities
  • Experience with DCS systems
  • Experienced in establishment of safe practices in a cGMP environment.
  • Proficient working with computer programs/applications such as Windows, VBA, MS Word, Excel, Access, etc.
  • Special Working Conditions:-Required manufacturing operations support on a rotating “on call” 24/7 basis.
  • Resource will be expected to follow our procedures for making GMP batch record changes, including following existing change management procedures including ITSCR (Information Technology Change Request) creation and execution.
  • Resource will be expected to make batch record edits, update functional specifications, develop and execute test protocols, develop and execute regression testing, coordinate with other functions for requirements definition, work planning and execution, as well as work independently to make changes.
  • Bachelor’s Degree.

Our client is a leading Pharmaceutical organization and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration. 
 
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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Client : Pyramid Consulting, Inc
             

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